Tag Archives: breakthrough therapies

Ibrutinib's Breakthrough to Market

FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly.
Posted in Biotech, FDA, healthcare, Market Access, Orphan Drugs, pricing, Regulatory, Sales, Strategy | Also tagged , , | 8 Comments

The List So Far: FDA Breakthrough Designations

With announcements pouring in since the beginning of this year, FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designations have so far totaled 25 as of the end of July. With a separate senior management team […]
Posted in Biotech, FDA, Orphan Drugs, Regulatory | Also tagged , , , , , , , , , , , | Leave a comment

FDA’s New Breakthrough Designation Process: A Patient Perspective

With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies—particularly for rare diseases. According to Teresa Barnes, Vice President of Patient Outreach & Program Support for the Coalition for […]
Posted in FDA, Orphan Drugs, People, R&D, Regulatory, Strategy | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

FDA: From Risk Aversion to Approval Activism

During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based […]
Posted in Agency Insight, Biotech, FDA, leadership, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy | Also tagged , , , , , , | 2 Comments

Patients on the Picket Line

Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.
Posted in Biotech, FDA, healthcare, Legal, Market Access, Regulatory, Safety | Also tagged , , , , , , , , , , , | Leave a comment
  • Categories

  • Meta